Yasuo Okumura1, Ikuo Fukuda2, Mashio Nakamura3, Norikazu Yamada4, Morimasa Takayama5, Hideaki Maeda6, Takeshi Yamashita7, Takanori Ikeda8, Makoto Mo9, Takao Kobayashi10, Akihiro Niwa11, Hiroshi Matsuo12, Hiroyoshi Yokoi13, Masatoshi Koga14, Tsutomu Yamazaki15, Atsushi Hirayama1. 1. Division of Cardiology, Department of Medicine, Nihon University School of Medicine. 2. Department of Cardiovascular Surgery, Hirosaki University. 3. Nakamura Medical Clinic. 4. Department of Cardiology, Kuwana City Medical Center. 5. Department of Cardiology, Sakakibara Heart Institute. 6. Division of Cardiovascular Surgery, Nihon University School of Medicine. 7. Department of Cardiovascular Medicine, The Cardiovascular Institute. 8. Department of Cardiovascular Medicine, Toho University Faculty of Medicine. 9. Department of Cardiovascular Surgery, Yokohama Minami Kyosai Hospital. 10. Hamamatsu Medical Center. 11. Hiratsuka Kyosai Hospital. 12. Matsuo Clinic. 13. Department of Cardiology, Fukuoka Sanno Hospital. 14. Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center. 15. Innovation and Research Support Center, International University of Health and Welfare.
Abstract
BACKGROUND: There is insufficient real-world data on the current status of Japanese patients with venous thromboembolism (VTE) or its treatment and prevention with rivaroxaban.Methods and Results: In this multicenter, prospective, observational study conducted in Japan, 1,039 patients with acute symptomatic/asymptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) with or without DVT prescribed rivaroxaban were enrolled at 152 institutions and observed for a median of 21.3 months. Mean age was 68.0±14.7 years, mean body weight was 60.3±14.1 kg, 59.0% were females, and 19.0% had active cancer. Incidences of recurrence or aggravation of symptomatic VTE (primary effectiveness outcome) and major bleeding (principal safety outcome) were 2.6% and 2.9% per patient-year, respectively. These outcomes did not differ between patients with DVT and those with PE (primary effectiveness outcome: 2.6% vs. 2.5% per patient-year, P=0.810; principal safety outcome: 3.5% vs. 2.4% per patient-year, P=0.394). The incidence of composite clinically relevant events, including recurrence or aggravation of symptomatic VTE, acute coronary syndrome, ischemic stroke, all-cause death, or major bleeding events, was 9.2% per patient-year. Multivariate analysis revealed that male sex, being underweight, having active cancer, chronic heart and lung disease, and previous stroke were independent determinants for composite clinically relevant events. CONCLUSIONS: In Japanese clinical practice, a single-drug approach with rivaroxaban was demonstrated to be a valuable treatment for a broad range of VTE patients.
BACKGROUND: There is insufficient real-world data on the current status of Japanese patients with venous thromboembolism (VTE) or its treatment and prevention with rivaroxaban.Methods and Results: In this multicenter, prospective, observational study conducted in Japan, 1,039 patients with acute symptomatic/asymptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE) with or without DVT prescribed rivaroxaban were enrolled at 152 institutions and observed for a median of 21.3 months. Mean age was 68.0±14.7 years, mean body weight was 60.3±14.1 kg, 59.0% were females, and 19.0% had active cancer. Incidences of recurrence or aggravation of symptomatic VTE (primary effectiveness outcome) and major bleeding (principal safety outcome) were 2.6% and 2.9% per patient-year, respectively. These outcomes did not differ between patients with DVT and those with PE (primary effectiveness outcome: 2.6% vs. 2.5% per patient-year, P=0.810; principal safety outcome: 3.5% vs. 2.4% per patient-year, P=0.394). The incidence of composite clinically relevant events, including recurrence or aggravation of symptomatic VTE, acute coronary syndrome, ischemic stroke, all-cause death, or major bleeding events, was 9.2% per patient-year. Multivariate analysis revealed that male sex, being underweight, having active cancer, chronic heart and lung disease, and previous stroke were independent determinants for composite clinically relevant events. CONCLUSIONS: In Japanese clinical practice, a single-drug approach with rivaroxaban was demonstrated to be a valuable treatment for a broad range of VTE patients.